OPTIS Integrated System Mobile Workstation
FDA 510(k) K151286 · Lightlab Imaging, Inc.
510(k) numberK151286
Submission
- Device name
- OPTIS Integrated System Mobile Workstation
- Applicant
- Lightlab Imaging, Inc.
Westford, MA, US - Received
- May 14, 2015
- Decision date
- August 5, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQQ – System, Imaging, Optical Coherence Tomography (Oct)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1560
- Specialty
- Radiology
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
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Questions and answers
When was OPTIS Integrated System Mobile Workstation cleared by the FDA?
OPTIS Integrated System Mobile Workstation (K151286) received a 510(k) decision of Substantially Equivalent on August 5, 2015, 83 days after the submission was received.
What is the product code of K151286?
The FDA product code is NQQ – System, Imaging, Optical Coherence Tomography (Oct), a Class II (moderate risk) device regulated under 21 CFR 892.1560.